I think there are many challenges to doing project management for medical devices vs other projects. One of the main challenges would be that there might not be a medical device to base your work off of. Other projects have history and its easy to modify something that you know has a history of working and is documented. Medical devices are relatively new compared to say building a multi-story building. This makes is easy for the project to become prey to scope creep due to you not having a very good previous model of the project. Another challenge that would go hand in hand with the main challenge stated is just advice in general not being available. In project management when initiating a project, you talk to people who are really doing the work but if they don’t have experience, you cant really find out what you didn’t know.